IMPLEX CEMENT RESTRICTOR SYSTEM
FDA 510(k) clearance K943378 · decided 1994-09-23
Clearance details
- K-number
- K943378
- Device name
- IMPLEX CEMENT RESTRICTOR SYSTEM
- Applicant
- Implex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-13
- Decision date
- 1994-09-23
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LZN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Artisan Bone Plug, Universal Cement Restrictor (K220838) | Howmedica Osteonics, Dba Stryker Orthopaedics | 2022-05-20 |
| TORNIER CEMENT RESTRICTOR (K061824) | Tornier | 2006-09-14 |
| CEMSTOP CEMENT RESTRICTOR (K032685) | Teknimed, S.A. | 2003-11-26 |
| BIOBUCK CEMENT RESTRICTOR (K023680) | Smith & Nephew, Inc. | 2002-11-19 |
| IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (K011943) | Kensey Nash Corp. | 2001-09-19 |
| SYNPLUG (K010840) | Isotis NV | 2001-04-20 |
| CEMSTOP CEMENT RESTRICTOR (K993841) | Encore Orthopedics, Inc. | 2000-05-04 |
| SHUTTLE STOP (K000587) | Isotis NV | 2000-05-04 |
| OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (K992462) | Howmedica Osteonics Corp. | 1999-08-13 |
| LINK CEMENT PLUG (K972411) | Turnkey Intergration USA, Inc. | 1997-08-29 |
| OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (K970779) | Osteonics Corp. | 1997-05-09 |
| ORTHOPLUG SOFT BONE DESIGN (K955632) | Sunmed, Inc. | 1996-02-27 |
Recalls involving this device
No recalls on record reference this clearance.